Sheath and electrical lead

ABSTRACT

The invention describes a steerable sheath for percutaneous epicardial access. The invention also describes a novel lead to facilitate left ventricular pacing and efficient defibrillation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119(e)to U.S. application Ser. No. 60/551,639 filed Mar. 9, 2004.

TECHNICAL FIELD

This invention relates to a novel sheath and electrical lead, and moreparticularly to a sheath in which the distal portion is angled and/orsteerable for optimal placement against the epicardium via percutaneousepicardial access, and an electrical lead for defibrillation and/orpacing at the epicardium.

BACKGROUND

A percutaneous, transvenous, endocardial approach has become standardpractice for catheter ablation of several types of arrhythmias andpacemaker lead implantation. However, this approach has limitations,including the inability to access intramural or epicardial portions ofarrhythmia circuits or inability to gain access to desirable tributariesof the coronary venous system. Technological improvements such ascooled-tip or larger-tip ablation catheters and different energy sourcesfor tissue ablation have not completely solved the problem.

Before the advent of percutaneous catheter-based endocardial ablationmethods, surgical epicardial approaches were used for treatment ofrefractory arrhythmias, particularly ventricular tachycardia (VT) andsupraventricular tachycardia (SVT), by using an accessory pathway.Epicardial ablation has been achieved through various methods, includingopen-chest surgery, thoracoscopy, and by way of epicardial vessels suchas the coronary sinus. However, despite the development ofcatheter-based, endocardial ablation techniques, some arrhythmiasubstrates might not be accessible from the endocardium. For example, VTfrom ischemic cardiomyopathy might have significant portions of thearrhythmia circuit in the epicardium. More recently, the percutaneousapproach for epicardial mapping and ablation of VT has been shown to befeasible, primarily in patients with ischemic cardiomyopathy.

Currently, epicardial pacing is often required in small children, inpatients with residual right-to-left shunts, and in patients withchambers that cannot be accessed by the transvenous route. Althoughendocardial pacing requires less extensive surgery than does epicardiallead implantation, there is concern about vascular obstruction, AV valveintegrity, and the limitations of lead accommodation during growth withepicardial pacing. The risks have generally been outweighed by thehigher acute and chronic stimulation thresholds of conventionalepicardial leads, resulting in premature battery depletion and the needfor subsequent operations. Recent advances in epicardial leads andsurgical approaches have demonstrated improved early pacing and sensingthresholds. Prior studies evaluating epicardial leads in children havehad low patient numbers or have involved series that predated both theintroduction of lithium iodide batteries and steroid-eluting leads.

Therefore, a steerable sheath delivery system for percutaneousepicarcial access and a permanent lead for pacing and/or defibrillatingepicardially is provided by the present invention.

SUMMARY

The invention describes a steerable sheath for percutaneous epicardialaccess. The invention also describes a novel lead to facilitate pacingand efficient defibrillation, particularly epicardial pacing anddefibrillation.

In one aspect, the invention provides a sheath including an elongateenclosure with at least one lumen. A sheath of the invention generallyhas a proximal and a distal portion defining a longitudinal axis. Thedistal portion of a sheath of the invention usually includes a tipregion that forms an angle with respect to the longitudinal axis of thesheath. The angle of the tip region is typically selected such that whenthe sheath is inserted into pericardium, the tip region of the sheath isadjacent to epicardium.

In one embodiment, the angle of the tip region is about 90°. In otherembodiments, the tip region also can include an electrode ring and/or anultrasound probe.

In another aspect, the invention provides a steerable sheath thatincludes a sheath having an elongate enclosure with at least one lumenhaving a proximal and distal portion that defines a longitudinal axis;and at least one sheath control mechanism for steerably operating thedistal portion of the sheath. In one embodiment, the sheath controlmechanism includes at least one control arm that extends from the sheathcontrol mechanism to the distal portion of the sheath and issubstantially parallel to the longitudinal axis of the sheath.

In certain embodiments, a sheath of the invention also can include atleast one monitoring device or sensing element. Representativemonitoring devices can include an intracardiac echo or an ultrasoundprobe device attached to the sheath. A representative sensing elementcan include one or more electrodes.

In another aspect, the invention provides an apparatus including asheath that has an elongate enclosure with at least one lumen, and ahandle capable of releasable attachment to the proximal portion of thesheath. A sheath of the invention generally has a proximal and distalportion that defines a longitudinal axis, and the distal portion usuallyincludes a tip region. A handle typically includes a sheath controlmechanism that engages the sheath to permit positioning of the tipregion thereof.

In one embodiment, a sheath control mechanism can include a rotatablesteering element that is substantially normal to the longitudinal axisof the sheath. In certain embodiments, the sheath control mechanismincludes a control arm engaging element and a steering element.Typically, a control arm engaging element and a steering element aresubstantially normal to the longitudinal axis of the handle. Forexample, a sheath can include one or more control arms that each have anengagement flange for engaging the control arm engagement element. Acontrol arm engagement element can include one or more female engagementregions to releasably engage an engagement flange of the control arm.

In another embodiment, the angle of the tip region of the sheath issubstantially normal to the longitudinal axis of the sheath (e.g., theangle of the tip region is 90° with respect to the longitudinal axis ofthe sheath). In certain embodiments, the tip region can include anelectrode ring or an ultrasound probe.

In still another aspect, the invention provides an apparatus including asheath, a handle capable of releasable attachment to the proximalportion of the sheath, and at least one diagnostic or therapeutic lead.The sheath generally includes an elongate enclosure with at least onelumen having a proximal and distal portion that defines a longitudinalaxis. The distal portion of a sheath of the invention generally includesa tip region. Typically, the handle includes a sheath control mechanismto engage the sheath to permit positioning of the tip region thereof.The diagnostic or therapeutic lead(s) usually have a size suitable forpositioning in the lumen of the sheath.

In yet another aspect, the invention provides methods for percutaneousplacement of an epicardial lead or other therapeutic or monitoringdevice. Such a method can include providing a sheath of the invention;inserting the distal portion of the sheath into pericardium; positioningthe tip region adjacent to epicardium; and inserting at least onediagnostic or therapeutic lead into the lumen. A sheath used in themethods of the invention generally includes an elongate enclosure withat least one lumen having a proximal and distal portion that defines alongitudinal axis; and a handle capable of attachment to the proximalportion of the sheath and having a sheath control mechanism. Typically,the distal portion of the sheath includes a tip region substantiallynormal to the longitudinal axis such that the sheath control mechanismcan engage the sheath to permit positioning of the tip region thereof.

In an embodiment of the method, the lead can be permanently positionedin the epicardium. In another embodiment, a sheath used in theabove-described methods further includes an electrode ring. Using such asheath, a method of the invention also can include assessing myocardialelectrical activity prior to inserting the diagnostic or therapeuticlead into the lumen. In yet another embodiment, a sheath used in theabove-described methods can further include an ultrasound probe. Usingsuch a sheath, a method of the invention also can include visualizingtissues and/or vessels prior to inserting the diagnostic or therapeuticlead into the lumen.

In still another aspect, the invention can include methods forpercutaneous placement of an epicardial lead or other therapeutic ormonitoring device. Such a method can include providing a sheath of theinvention; inserting the distal portion of the sheath into pericardium;positioning the tip region adjacent to epicardium; inserting at leastone diagnostic or therapeutic lead into the lumen; and removing thehandle such that at least one of the sheath or the lead remain in thepericardium. As described above, a sheath for use in the methods of theinvention can include an elongate enclosure with at least one lumenhaving a proximal and distal portion that defines a longitudinal axis;and a handle releasably attached to the proximal portion of the sheaththat includes a sheath control mechanism. Generally, the distal portionof the sheath includes a tip region substantially normal to thelongitudinal axis of the sheath, which allows the sheath controlmechanism to engage the sheath and permit positioning of the tip regionthereof.

In another aspect, the invention provides a kit for percutaneousplacement of an epicardial lead. A kit of the invention can include asheath and at least one diagnostic or therapeutic lead. Generally, asheath of the invention includes an elongate enclosure with at least onelumen having a proximal portion and a distal portion that defines alongitudinal axis and a handle capable of releasable attachment to theproximal portion of the sheath and having a sheath control mechanism.Generally, the distal portion of a sheath of the invention includes atip region, such that the sheath control mechanism can engage the sheathto permit positioning of the tip region thereof.

In some embodiments of the above-described sheath, the elongateenclosure also can have an access port. An access port can be used inthe methods of the invention to remove the sheath such that the leadremains in the pericardium or to remove the lead and the handle suchthat the sheath remains in the pericardium.

In still another aspect, the invention provides a deployable leadcomprising at least one arm, the arm having a distal end and a hingedend, wherein the arm comprises at least one electrode. Typically, thehinged end of the arms is attached to a longitudinal body of adiagnostic or therapeutic lead. In different embodiments of theinvention, the electrodes can be attached to the arms at the distal endof the arms, or can be attached to the arms at a position medial to thedistal end and the hinged end of the arm. Generally, the distal ends ofthe arms move through an angle α relative to the longitudinal axis ofthe diagnostic or therapeutic lead, for example, between about 0° andabout 90° or between about 0° and about 180° relative to thelongitudinal axis of the diagnostic or therapeutic lead.

In another embodiment, the arm also can include a membranous material.In certain embodiments, the material can attached to a second arm,and/or can be attached to a longitudinal body of a diagnostic ortherapeutic lead. In some embodiments, the material is conductive (e.g.,the material can further include electrodes).

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In addition, the materials, methods, andexamples are illustrative only and not intended to be limiting. Allpublications, patent applications, patents, and other referencesmentioned herein are incorporated by reference in their entirety. Incase of conflict, the present specification, including definitions, willcontrol.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedrawings and detailed description, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a photograph of the distal portion of a sheath of theinvention in which the tip is perpendicular to epicardium.

FIG. 2 is a photograph of a ring electrode at the distal portion of thesheath to permit electrical tissue assessment before lead deployment.

FIG. 3 is a photograph of a sheath of the invention having a steeringmechanism at the distal portion.

FIG. 4 is a photograph showing an embodiment in which a sheath of theinvention is detachable from a handle. The metal projections are pulllevers for steering the distal portion of the sheath.

FIG. 5 is a photograph showing a deployed lead of the invention. Thisembodiment also includes a distal straight screw for epicardial atrialpacing, proximal electrode rings for epicardial ventricular pacing, andmesh material for defibrillation or multi-site pacing.

FIG. 6 is a photograph of a lead of the invention in a retractedposition in a sheath.

FIG. 7 is a photograph showing an example of how the shape of the distalportion of a sheath of the invention facilitates lead fixation intoepicardium.

FIG. 8 is a photograph that shows an embodiment of a sheath of theinvention with an access port into which a lead can be introduced.

DETAILED DESCRIPTION

Recent advances in cardiology have resulted in an enhanced ability toplace cardiac pacing and other leads in non-traditional locations, suchas in the vicinity of the left ventricle. Due to the risk ofthromboembolism, intra-cavitary left-ventricular lead placement isgenerally avoided. The recent introduction of biventricular pacing andits documented success in multiple randomized, prospective clinicaltrials has led to great interest in placement of permanent leads capableof left ventricular pacing. While biventricular leads were initiallyplaced epicardially, due to the need for thoracotomy (and its attendantrisk and prolonged recovery), coronary sinus venous access has beenadopted as the primary means of lead placement. Leads designed to pacethe left ventricle are threaded through the coronary veins to epicardialvenous positions. However, due to the variability of human anatomy andtechnical limitations with this approach, as many as 8-12% of patientsin prospective trials have been unable to receive this form of therapy.Clearly, a new method of rapidly delivering leads to the left ventriclewould be of great utility in the therapy of the 5 million patients inthe U.S. with heart failure. This invention describes such a technology.

Additionally, this invention describes a novel lead, capable of leftventricular pacing and defibrillation with very low defibrillationthresholds. Such a lead may permit widespread applicability of leftventricular pacing, which may be as effective as biventricular pacing,and defibrillation with a single lead. Importantly, biventricular pacingis facilitated and improved by the capability of selecting from multiplepacing sites within a single lead. Furthermore, enhanced defibrillationefficacy by means of this novel lead may result in greater longevity ofsmaller implantable defibrillators. If defibrillation effectiveness issufficient to eliminate the need for defibrillation threshold testing, abroader array of health care providers such as general cardiologists orgeneral surgeons could perform implantation, thereby facilitating wideradoption of this therapy. Additionally, the introduction of painlessdefibrillation shocks by means of autonomic nervous stimulation may bepossible, as autonomic and pain fibers are epicardially located.

Sheath

FIG. 1 shows a distal 4 portion and tip region 8 of a sheath 2 of theinvention approximated against the epicardium E. The tip region 8 of thesheath 2 has a curved shape so as to position a lead or ablationelectrode within the pericardium P perpendicular to the surface of theepicardium E. The angle α of the tip region 8 is relative to thelongitudinal axis L of the sheath 2. In some embodiments, the angle α ofthe tip region 8 is substantially normal to the longitudinal axis L ofthe sheath 2. FIG. 1 shows an angle α at the tip region 8 of about 90°.The curved shape at the tip region of a sheath of the invention canfacilitate flush contact with and active fixation of a lead or ablationelectrode onto the epicardium E.

FIG. 2 shows the distal 4 portion of a sheath 2 of the invention,including the lumen 7 of the sheath. FIG. 2 shows an embodiment in whichan electrode ring 10 at the tip region 8 of a sheath 2 permits pacing toassess myocardial viability and phrenic capture at multiple sites priorto lead fixation, further facilitating lead placement. In addition, anultrasound probe can be integrated into a sheath of the invention.Ultrasound imaging permits imaging of tissues and epicardial vessels asthe sheath passes over the epicardium prior to lead fixation. In someembodiments, the sheath can have more than one lumen to permit placementof more than one sensing element or monitoring device.

The invention further includes a steerable sheath as shown in FIG. 3.FIG. 3 shows an elongated sheath 2 having a proximal 6 and distal 4portion that defines a longitudinal axis L. The embodiment of thesteerable sheath shown in FIG. 3 also has a sheath control mechanism 12for steerably operating the distal 4 portion of the sheath 2. The sheathcontrol mechanism 12 shown in FIG. 3 includes a steering element 18 thatcan be at least partially rotated clockwise and counterclockwise, whichactuates internal wires extending down the longitudinal axis of a sheathof the invention.

Many types of control mechanisms for steering the distal portion of asheath are suitable for use in the present invention. In the embodimentshown in FIG. 3, the sheath control mechanism 12 can include at leastone control arm 16 (not visible) that extends from the sheath controlmechanism 12 to the distal 4 portion of the sheath and is substantiallyparallel to the longitudinal axis L of the sheath 2. Clockwise orcounterclockwise rotation of the steering element 18 results in movementof the distal 4 portion of the sheath via the control arm 16.

A steerable sheath of the invention can be deployed percutaneouslyutilizing known techniques (see, for example, Sosa et al., 1996, J.Cardiovasc. Electrophysiol., 7:531-6). Access to the pericardium hasbeen well described and methods are well known to those of skill in theart. A steerable sheath as described herein can be used for manipulatingand affixing temporary or permanent leads for pacing, defibrillation,ablation, or other diagnostic or therapeutic uses in the epicardium.

FIG. 4 shows an embodiment of a sheath apparatus in which the handle 14is detachable from the proximal 6 portion of the sheath 2. FIG. 4 showsthe proximal 6 portion of an elongated sheath and the distal portion ofa handle 14. A detachable handle 14 in an apparatus of the inventionwill include a sheath control mechanism 12, which is able to detachablyengage the proximal 6 portion of a sheath 2 to permit positioning of thedistal 4 portion and the tip region 8 of the sheath 2 adjacent toepicardium E. In embodiments in which the handle is detached, theproximal portion of the sheath can be sutured in place to providegreater lead stability.

In one embodiment, a sheath control mechanism 12 can include a rotatablesteering element 18 such as that shown in FIG. 1. In some embodiments inwhich the longitudinal axis L of the sheath 2 is in a relaxed position(i.e., not being steered), such a rotatable steering element 18 isgenerally substantially normal to the longitudinal axis L of the sheath2.

In another embodiment such as the embodiment shown in FIG. 4, a sheathcontrol mechanism 12 can include a control arm engagement element 20 anda rotatable steering element 18. In the embodiment shown in FIG. 4, thecontrol arm engagement element 20 and the rotatable steering element 18are substantially normal to a longitudinal axis L of the handle 14.

In the embodiment shown in FIG. 4, the sheath 2 includes one or morecontrol arms 16 that each can have an engagement flange 22 for engagingthe control arm engagement element 20 on the handle 14. The control armengagement element 20 shown in FIG. 4 contains one or more femaleengagement elements 24 to releasably engage an engagement flange 22 of acontrol arm 16. Although not necessary, it may be desirable to havecontrol arms 16 that are low profile so that the control arms 16 do notprotrude from the sheath after the handle is removed. Low profilecontrol arms would be advantageous in cases in which the sheath is to beleft permanently in place.

Generally, two or more control arms are used to maneuver a steerablesheath of the invention. FIG. 4 shows three control arms 16 and threecorresponding female engagement elements 24. In other embodiments, anelectrical lead can be positioned along the longitudinal axis L of asheath 2 in a similar manner as a control arm 16. The electrical leadcan connect to a removable handle 14 via female engagement elements 24.

In an embodiment, the tip region of the sheath in an apparatus of theinvention can include an electrode ring 10, such as that shown in FIG.2, or an ultrasound probe or a fiberoptic light source and window (notshown).

In another embodiment of an apparatus of the invention, a peel-awaysheath can be used with a removable handle. Peel-away sheaths are wellknown in the art and are usually opened by slitting or tearing at aperforation in the sheath. A peel-away sheath can still accommodate anelectrode ring at the tip region of a sheath for initial pacing. Such anelectrode ring can be discontinuous, or it can be weakened at a positioncorresponding to the position in the sheath that is opened.

The invention also provides a kit for percutaneous placement of anepicardial lead. Such a kit can include a sheath of the invention and atleast one diagnostic or therapeutic lead 36 having a size suitable forpositioning in the at least one lumen 7 of a sheath of the invention.

Deployable Lead

A deployable lead of the invention can be percutaneously placed tofacilitate epicardial left ventricular pacing. Epicardial leftventricular pacing is useful, for example, in biventricular pacing. Sucha lead of the invention also can facilitate lower defibrillationthresholds and could be useful for other technologies such as cardiaccontraction modulation.

FIG. 5 shows a deployable lead 28 of the invention. A deployable lead 28of the invention includes at least one arm 30 having a distal end 34 anda hinged end 32. Usually, the arm(s) 30 of a deployable lead 28 of theinvention include at least one electrode. Such electrodes can beattached to the arms 30 at the distal end 34 of the arms 30, orelectrodes can be attached to the arms 30 at a position medial to thedistal end 34 and the hinged end 32 of the arm 30. In some embodiments,the hinged end 32 of the arms 30 can be attached to a longitudinal bodyof a diagnostic or therapeutic lead 36.

FIG. 5 shows a deployable lead 28 of the invention containing anoptional membranous material 38. Such a material can be used to enlargethe defibrillation surface area provided by the deployable lead. Such amembranous material 38 can be attached to a second arm 30, or can beattached to a longitudinal body of a diagnostic or therapeutic lead 36.In certain embodiments, the membranous material 38 can be conductive toenhance defibrillation and also may contain discrete electrodes forpacing. In certain embodiments, a part or portion of the membranousmaterial 38 can be conductive, while the opposing part or portion of themembranous material 38 can be reflective, to thereby direct the energy.For example, the conductive portion (or discrete electrodes) can be theinternal layer of the membranous material 38, while the reflectiveportion can be the outside layer.

The arms 30 of a deployable lead 28 of the invention are adjacent to themain lead body in the low profile position (FIG. 6). When the sheath iswithdrawn, the arms are deployed, thereby moving the distal ends of thearms through an angle α relative to the longitudinal axis of adiagnostic or therapeutic lead 36. For example, the angle α can bebetween about 0° and about 90° relative to the longitudinal axis of thediagnostic or therapeutic lead 36, or the angle α can be between about0° and about 180° relative to the longitudinal axis of the diagnostic ortherapeutic lead 36. Deployment can be due, for example, to springaction, or by making the arms from materials having shape-memory.

FIG. 6 shows a deployable lead 28 of the invention in a retracted stage.In the embodiment shown in FIG. 6, the diagnostic or therapeutic lead 36to which the deployable lead is attached can be pulled back into asheath, thereby retracting the deployable lead of the invention. To moveor reposition the arms 30 of a deployable lead 28, the sheath 2 could beadvanced over the lead 36, bringing the arms 30 together until adesirable position is found.

In another embodiment, multiple arms 30 that can be deployed todifferent angles a relative to the longitudinal axis L of the sheath 2can be used to create a fan-like structure upon deployment. Electrodeson the arms or at unique sites within a membranous material 38 couldallow for simultaneous or sequential left ventricular pacing or leftventricular sub-threshold stimulation. The availability of multipleelectrodes at different positions along an arm or within a membranousmaterial permits selection of different pacing sites using a singledeployed lead. Such selection is useful in the event of a change inthreshold at one site, the development of phrenic stimulation withchanging body position, or the evaluation of the hemodynamic benefit ofpacing at different unipolar or bipolar sites. Additionally, the optionof simultaneously or sequentially pacing from multiple sites in a supra-or sub-threshold manner may add additional benefits in the setting ofrefractory heart failure.

In an alternative embodiment (not shown), the arms 30 can be deployedusing, for example, a pull wire or a screw-type mechanism. Such a pullwire or screw mechanism can be at the proximal end 6 of the sheath formanipulation by the user. A pull wire or screw mechanism also can beused to retract the arms. In the retracted position, the arms generallylay parallel to the longitudinal axis L of the sheath 2.

Electrode rings and/or one or more coil electrodes also can be used forventricular pacing and/or stimulation in the epicardium. Within thepericardial space, ring electrode contact is assured. The embodiment ofthe deployable lead shown in FIG. 5, which includes electrode rings 40and a coil electrode 42, can provide dual chamber pacing and activedefibrillation from the same lead. The coil electrode 42 shown in FIG. 5is essentially contiguous with the longitudinal axis L of the sheath 2.In certain embodiments, an electrode (not limited to coil electrodes)projects from the distal portion of the sheath 2 at an angle. Forexample, an electrode projecting at an angle can be affixed to theoutside of the sheath 2 or can be slidably deployed and retracted from ahole in the sheath 2. Such an electrode (retractable or fixed) caninclude a barb (not shown) to assist in anchoring the electrode to theepicardium.

In another embodiment, a lead can have a sharp distal end that can beprotected within the sheath or exposed. Such a lead can be introducedinto the coronary sinus in the same manner in which existing leads areintroduced. Once in the coronary sinus, the sharp distal lead can beexposed and used to pierce the venous structure to allow the sheath toexit to the epicardium.

Methods for Using a Sheath or Lead of the Invention

A steerable sheath of the invention facilitates placement ofbiventricular pacing leads or ablation catheters. FIG. 7 shows aphotograph in which the sheath 2 has been made translucent so as todemonstrate how a diagnostic or therapeutic lead 36 can be introducedinto the sheath 2 and positioned adjacent to the epicardium E to allowactive fixation of the lead 36. In addition to pacing leads (or wires)and ablation catheters (or electrodes), a steerable sheath of theinvention also can be used to deliver, for example, sonomicrometers or(wireless) physiomonitors. A steerable sheath of the invention also canbe used for therapeutic injections of, for example, cardiac myocytes.

Generally, a method of the invention can include providing a steerablesheath of the invention, inserting the distal 4 portion of the sheath 2into pericardium P, positioning the tip region 8 adjacent to epicardiumE, and inserting at least one diagnostic or therapeutic lead 36 into thelumen 7 of the sheath 2. In an embodiment, the diagnostic or therapeuticlead 36 can be permanently positioned in the epicardium E. As describedabove, a steerable sheath of the invention can include a monitoringdevice or a sensing element such as an electrode ring or an ultrasoundprobe. In those cases, a method of the invention can further includeassessing myocardial electrical activity and/or visualizing tissuesand/or vessels. In another embodiment, the method described above can bepracticed, followed by removing the handle 14 such that either or boththe sheath 2 or the lead 36 remain in the pericardium P.

FIG. 8 shows an embodiment in which the sheath 2 has an access port 26such that the sheath 2 can be removed once a diagnostic or therapeuticlead 36 is introduced. Such an access port 26 in a sheath 2 iscontiguous with the lumen 7 of a sheath 2. In certain embodiments of asheath of the invention, where the sheath 2 has an access port 26, thelead 36 and the handle 14 can be removed, thereby allowing the sheath 2to remain in the pericardium P as described above. As described above,in the absence of an access port 26, a peel-away sheath can be used.

The embodiment of the sheath shown, for example, in FIG. 8, would beamenable to non-invasive magnetic repositioning. For example, using amagnetic field-type steering device, a lead such as the one shown inFIG. 8 could be actively maneuvered using magnetic guidance. Therefore,the lead can be repositioned without the need for additional invasiveintervention. In addition, the presence of a non-magnetic sheath left inplace permanently may facilitate magnetic manipulation of leads.

Delivery

The steerable sheath device as described herein can be used for bothsubxiphoid and medial intercostal transthoracic delivery of a lead.Visceral and parietal pericardial separation is typically widest in thesubxiphoid as well as right and left second intercostal space region(site of reflection). In addition, a steerable sheath of the inventioncan be used for transcoronary venous delivery of a lead, intramyocardiallead delivery, or intracavitary lead placement.

In a transcoronary venous delivery system, the coronary sinus would becannulated in the usual fashion. However, a Seldinger-type process wouldbe used to puncture the coronary venous system. Anatomically, the sitesthat would be least likely to result in mediastinal bleeding or arterialdamage would be the posterior wall of the great cardiac veinapproximately 5-10 mm distal to the posterolateral vein. Entry into thepericardium also can be achieved by piercing the right atrial appendageas is known in the art. Alternatively, a superior puncture in thecoronary sinus itself between the first and second atrial veins presentslittle risk of arterial damage because of the atrial location of thecoronary sinus at this site, particularly in the superior or atrialorientation. Once the pericardium is accessed through this site, leadmanipulation can be directed in a more ventricular fashion. Ifpericardial effusion is found to be prohibitive, a modification of thedelivery system using a flanged or other closure device can be used tominimize ooze from the venous system.

For intramyocardial lead delivery, intramyocardial puncture from theright ventricular septum can be performed and, for example, using anembodiment of the lead such as that shown in FIG. 8, the lead can beplaced in a mid-myocardial septal location. This location may helpshorten the QRS duration and synchrony of ventricular contraction. Themid and distal portions of the ventricular septum exhibit considerableanisotropy with right ventricular fibers following the course of theacute marginal arteries and the left ventricular septal fibers followingthe course of the septal perforators more deeply and the left anteriordescending artery more superficially. Thus, an intramyocardial locationof a lead in this portion of the septum is unlikely to producesignificant QRS shortening. However, a lead placed in this fashioninferior to the membranous interventricular septum (below the bundle ofHis) would likely produce simultaneous biventricular activation. For anintramyocardial placement, Thebesian vessels that drain rightventricular myocardial blood to the chamber of the right ventricle canbe accessed using this delivery system.

Intracavitary lead placement would require transeptal puncture of theintraventricular septum with the use of a closure device appended to thelead. Such a closure device can have a similar coating to those ofexisting closure devices or arterial patches. A lead could be placed inthe endocardial portion of the left ventricular free wall using thistechnique.

Uses for Pacing

For uses involving a pacemaker or biventricular pacing, a leftventricular lead delivered pericardially using a sheath of the inventionmight be preferential over coronary sinus delivery for the followingreasons. First, a larger surface area of stimulation can be achievedusing a left ventricular lead. Second, although the coronary veinsdemonstrate a large anastomotic network around the ventricle, certainportions of the ventricle have limited venous drainage from branches ofthe main coronary veins. Third, in certain locations, notably themid-lateral and mid-posterior locations of the coronary venousvasculature, the epicardial portion of the veins has a large diameter.Therefore, a conventional pacing lead likely wedges into the perforatingportion of these veins, and thus, stimulation may be occurringmid-myocardially rather than epicardially. Fourth, a sheath of theinvention as described herein may be particularly applicable forsimultaneous insertion of peizo electric crystals and transducers tomeasure contractility change. This may allow a one-step, single-accesssystem to place leads at optimal sites and assess improvement withpacing both locally at a site and at a distance to the site.

A sheath of the invention also can be used for pacing with a combinationof other subthreshold stimulation delivery systems.

Uses for Defibrillation

For uses involving defibrillators, a sheath of the invention may beparticularly useful for selective deployment of defibrillator coils inan epicardial posterior/left ventricular location. The ability to placea wide area coil electrode in the posterior left ventricle just opposedto myocardial tissue in addition to an endocardially placed coil maysignificantly decrease the defibrillation threshold. Iterations thatinclude rapid pacing of the right cardiac nerve (see below) may furtherdecrease patient discomfort prior to the delivery of an otherwisepainful shock.

Uses for Ablation

For uses involving ablation, epicardial pathways have continued to limitablation success in some patients with, for example,Wolff-Parkinson-White syndrome. While pericardial approaches have beenused for epicardial ablation, the removable nature of the handle in anapparatus of the invention and the fixity of screwed-in electrodes mayallow for both mechanical and specific radiofrequency ablation targets.

In addition, the oblique sinus of the pericardial space is subjacent topotential pulmonary vein-to-pulmonary vein connections, either throughthe vena venarum or the vein of Marshall. This portion of the heart ishighly mobile and would likely be technically demanding via existingpericardial approaches without a screw-in mechanism to map and ablatespecifically.

Further, when epicardial pathways use the coronary venous system, fearof arterial damage has limited the ablation energy delivered.High-energy endocardial ablation, cryoablation, and pericardial ablationwith standard catheter delivery systems are plagued by the inaccuracy ofdefining lesion size and limiting lesions to the venous system alone.With the steerable sheath described herein, an ablating lead can bescrewed specifically into a vein of interest. Using traction, the veincan be moved from the neighboring artery and low energy lesionsdelivered to the venous wall alone.

Ablation for ventricular tachycardia is likely enhanced by existingpericardial approaches for ablation. However, this benefit may beenhanced even more if the ablating electrode could be fixed so as toallow more accurate endocardial manipulation of a catheter to anadjacent site to the fixed epicardial electrode. Radiofrequency ormicrowave energy could be delivered between these two electrodes toensure transmural ablation.

Current attempts at radiofrequency ablation to promoteneovascularization in patients with endstage ischemic heart disease havebeen met with minimal or no success. Part of the reason for this lack ofor low success is the inability to perform multiple sequentialprocedures after accessing benefit. The deployable lead of the inventionand the steerable sheath of the invention would allow epicardialrevascularization with minimal invasiveness and also would allow leadshaft mobility and sequential fixation of the lead tip.

Other Uses

A steerable sheath of the invention and/or a deployable lead of theinvention also can be used to treat coronary vasospasm. While theetiology of coronary vasospasm is largely dependent on humoral factors,a neural component is under investigation. If a significant neuralcomponent/tachycardia is found, the use of small fixed electrodes in thecoronary vasculature may allow for modulation of the coronary arterialtone. This application may potentially benefit the closely relatedsyndrome of inadequate coronary vasodilator reserve (syndrome X).

A steerable sheath or deployable lead of the invention also can be usedin neuroregulation. While the autonomic and pain fiber innovation of theheart is quite wide spread, distinct clustering of these nervous tissuesoccurs insofar as to allow classification of cardiac nerves. The rightcardiac nerve associated predominately with parasympathetic efferentsand pain fiber afferents is located in the region of the medialsuperficial superior vena caval/RA junction. Pericardial access usingany of the above-described delivery techniques can be used to gainaccess to the transverse sinus and through the transverse sinus to theaortocaval recess to allow placement of a lead. Devices capable ofmodulating the nervous system may allow cardiac modulation both for painmodification, heart rate, AV node modulation, and potential effects onarrhythmogenicity by modulating the autonomic tone. The left/posteriorcardiac plexus would be readily accessible, particularly withtranscoronary vein puncture techniques. Finally, the left anterior fatpad with parasympathetic afferent as well as efferent fibers can beaccessed via the oblique sinus posterior to the left pulmonary veins.

A steerable sheath or deployable lead of the invention also can be usedfor phrenic stimulation. Patients with diaphragmatic paralysis fromcervical trauma sometimes require operative placement of phrenic nervestimulators. At times, repeat procedures are required in these patientsto either change the lead or the lead location. Both the right and leftphrenic nerves may be accessed through the pericardial space and using asteerable sheath of the invention, pericardial stimulators may be placedin a similar fashion to existing pacemakers.

A steerable sheath or deployable lead of the invention also can be usedto treat neurocardiogenic syncope. One of the multitude of hypothesizedfactors precipitating neurocardiogenic syncope is unexplained greatcaval veins dilation. The suprasplenic vein, proximal hepatic vein,inferior vena cava, and superior vena cava are accessible through thepericardial reflections. Rapid pacing to increase venomotor tone can beeffected using a steerable sheath of the invention. The manipulatableyet fixed nature of a steerable sheath of the invention also would beideally suited for sustained/eluting delivery of cardiac and othergenetic therapies and drug delivery systems. Epicardial pacing orcardiac contraction modulation impulses may be particularly helpful intreating neurocardiogenic syncope by increasing the force of contractionin addition to modifying autonomic function.

A deployable lead of the invention also can be used in patients thathave congestive heart failure. An epicardially-placed deployable leadcan be used as a pump to facilitate cardiac contraction. Additionally,deployment of multiple arms or multiple leads may help prevent cardiacmechanical dilation.

OTHER EMBODIMENTS

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are within the scope of thefollowing claims.

1. A deployable diagnostic or therapeutic implantable lead comprising alead body having a longitudinal axis and at least one arm, said armhaving a distal end and a hinged end, wherein, when said deployable leadis in a retracted position, said arm is adjacent to said longitudinalaxis of said lead body and, when said deployable lead is in a deployedposition, the distal end of said arm moves through an angle α, whereinangle α is between about 0° and about 180° relative to said longitudinalaxis of said lead body, said deployable lead further comprising amembranous material attached to said arm, wherein said arm comprisesmultiple electrodes.
 2. The deployable lead of claim 1, wherein saidelectrodes are attached to said arms at said distal end of said arms. 3.The deployable lead of claim 1, wherein said electrodes are attached tosaid arms at a position medial to said distal end and said hinged end ofsaid arm.
 4. The deployable lead of claim 1, wherein the hinged end ofthe arms is attached to said lead body of said deployable diagnostic ortherapeutic lead.
 5. The deployable lead of claim 1, wherein saidmembranous material is further attached to a second arm.
 6. Thedeployable lead of claim 1, wherein said membranous material is attachedto said lead body of said deployable diagnostic or therapeutic lead. 7.The deployable lead of claim 1, wherein said membranous material isconductive.
 8. The deployable lead of claim 1, wherein said membranousmaterial further comprises electrodes.
 9. The deployable lead of claim1, wherein said angle α is between about 0° and about 90° relative tothe longitudinal axis of said lead body.
 10. The deployable lead ofclaim 1, wherein said angle α is between about 0° and about 180°relative to the longitudinal axis of said lead body.